Congratulations to all of us quality managers. We have a new standard. ISO 9001: 2008. This is really an exciting moment for quality managers. In order to celebrate this event in a way that only quality managers know how, I prepared here a comparison article between the ISO 9001:2000 and the new born ISO 9001:2008. I also included my comments regarding my experience and my perspective of things.
At the end of it I will summon the new requirements from the new ISO 9001:2008 standard. Paragraph number 0.1 - Changes here are a statement about whom and where the standard is including any statutory requirements and have the same scale as any customer or regulatory requirements. It's also clarified that these requirements are restricted to those applicable to the product.
Paragraph number 0.4 - There is a comment that state that the new standard is made due consideration to ISO 14001:2004.
My comment - Of course. The world is getting greener every day so they must remind you of the ISO 14001 standard. I believe and recommend to any organization that is needed of the ISO 14001 standard to implement also the 9001. There is a big correlation between these two. They actually help one another.
Paragraph number 1 - Statutory requirements had been referred in connection with purchased products and product realization. Second note explains that a statutory requirement can be a legal requirement.
My comment - After so many years of auditions the long last debate had been settled. Statutory legal requirements and statutory requirements are obliged to the purchasing processes. It was always an open area that no one had the correct answer: is your supplier must follow the law or not? Apparently yes.
Paragraph number 2 - Normative reference - the ISO 9000 is now referred to ISO 9000:2005
Paragraph number 3 - Explanation about what is a customer and what is an organization and what is a supplier had been removed.
Paragraph number 4.1 - Clause a - The word "determine" is replacing the "identify". A note had been added stating that a purchased processes are regarded as purchasing products and another note that demand that these processes would be controlled as far as products. My comment - Come on, like it wasn't obvious before....
Paragraph number 4.2.1 - Slight change of words but when you examine the change you realize the meaning is the same. Note2 was changed - a single document may include requirements for more than one procedure and requirements of one procedure may appear in more than one document. My comment - It's about time. A lot of headaches are vowed to be save. If your audit was one of the old school and demanded everything by the book - now you may combine two quality procedures to one document: Job description and training for example or you can split one document into two. How ever it is suitable for you as long as you provide the demands.
Paragraph number 4.2.3 - A clarification that external documentation are the ones needed for the quality management system.
Paragraph number 5.1 - Clause a - the word "statutory" had been added.
Paragraph number 5.5.2 - An addition for a demand that the management representative would be a member of the organization's management.
My comment - That addition puts all external consultants at risk - you can no longer be the management representative. That sets a whole new line of forms and documentations for you to develop in order that the external consultants would be considered as a management representative.
Paragraph number 6.2 - Change of words from "affecting product quality" to "affecting conformity to product requirements"
Paragraph number 6.2.2 - Clause b -"provide training or take other actions to satisfy these needs" changed to "where applicable training needs to be provided to achieve the necessary competence". My comment - It all goes back to defining .You defined what is necessary now you must provide it - nothing is new.
Clause c - you must ensure that the training is with competence rather than if it was an effective training.
My comment - On one hand it is an improvement. The training must be reviewed before. But I think it's not such an improvement. Instead of testing your employees if they got anything of the training you must now check the training itself before. Only time will tell...
Paragraph number 6.3 - Clause c - information systems are included. My comment - They are totally right!
Paragraph number 6.4 - A new note: noise, humidity, temperatures are part of a working environment.
My comment - That also puts an old debate aside. No longer can cruel owners of factories ignore these factors. Wait until they will combine OHSAS 18001...
Paragraph number 7.1 - Clause c - measurement had been added to the activities.
Paragraph number 7.2.1 - Clause a - change of words - not of the meaning. Clause c- the word 'applicable' replaces 'related'. Clause d - change of words - not of meaning. A note has been added to explain what is the meaning of "post delivery activities".
My comment - I agree with the "post delivery activities" - it wasn't clear enough for my opinion. Paragraph number 7.3.1 - A note had been added clarifying that design review, verification and validation are separated processes but they might be conducted together.
Paragraph number 7.3.3- A change of wording. A note had been added clarifying what is included in "preservation of product".
Paragraph number 7.5.3 - A requirement added specifying that product traceability must be included throughout the product realization.
My comment - That actually means that the product must be identifying not only on the shelves but also throughout the realization process.
Paragraph number 7.5.4 - A change of words to in the requirement to inform the customer of any problem regarding his property. The note had been amended that also personal data is included as customer's property.
Paragraph number 7.5.5 - A change of words: from "conformity of" to "in order to maintain conformity to requirements"
Paragraph number 7.6 - A change of words: from "devices" to "equipment" The reference to paragraph 7.2.1 had been removed. Clause c - from "be identified to enable the"to " identification to enable their"
Changes in the notes: Note 1 - the reference to ISO 100012-2 had been removed. Note 3 - explanation about when configuration of computer must be applied when the computer is used for monitor and measurements processes.
My comment - That means that from now on a computer that provides any kind of measurements services is considered a monitoring and measuring device. How can one calibrate a computer? Ask the supplier or your system administrator. They will know better than anyone.
Paragraph number 8.2.1 - A note had been added to suggest some means of conducting customer satisfaction evaluation.
Paragraph number 8.2.2- Requirements for the audit evidence and results had been added and also that the management is responsible for ensuring preventive and corrective action to be taken. The reference to the ISO 10011 is changed to ISO 19011.
Paragraph number 8.2.3 - A change of words: "to ensure conformity of the product" had been removed. A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.
Paragraph number 8.2.4 - A change of word: "maintain evidence of conformity with acceptance criteria" had been removed but it is still a requirement.
Paragraph number 8.3 - An addition - Clause d - specify how to deal with a nonconforming product that was discovered after delivery - but actually there nothing new only that they moved it to a new clause.
So, what are the new requirements of the new standard?
· Statutory requirements are given scale as any other legal or customer's requirements.
· The statutory requirements are including the suppliers as well.
· A purchased process is just like any other product that the organization purchased. If it's affecting the product it must be under the quality system.
· You may include two quality processes in one document and split one process to two documents.
· The management representative must be a member of the management.
· A requirement to ensure that trainings are suitable for the product in advance and not to check if the training was effective after it was taken.
· Information system in now officially considered as a substructure.
· Parameters such as humidity, noise and temperatures, concerning the employees' health are considered as working environment.
· Measuring is considered as one of the activities of product realization.
· The product must be identifying not only on the shelves but also throughout the realization process.
· The management is now responsible for preventive and corrective actions regarding nonconformities that were discovered during audit.
· The organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.
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